Stroke, IschemicVESTANCT05299034
Optimizing the Radiological Selection and Transfer Model in Stroke Patients Presenting 6-24h After Onset (VESTA Study)
An observational study of Stroke, Ischemic, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
We aim to optimize the radiological selection and the transfer model in patients with a 6-24h stroke for a fairer and broader access to a reperfusion treatment. The specific objectives are: 1. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Multiparametric imaging and Non contrast CT+CT angiography
- How many people
- 2,173 participants
- Where
- 1 siteSpain
- Study dates
- 14 Jan 2022to 15 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with stroke suspiction in Catalonia included in the CICAT registry
- SUBSTUDY 1. OPTIMIZATION OF IMAGING SELECTION METHODS FOR SELECTING STROKE PATIENTS FOR REPERFUSION TREATMENT IN THE EXTENDED WINDOW.
- Inclusion criteria: Consecutive patients registered in the CICAT registry between the years 2019 and 2021 with a stroke who meet the following criteria
- Age older than 18 years,
- Diagnosis of acute cerebral infarction,
- More than six hours of evolution or uncertain chronology of symptoms,
- Absence of disability prior to stroke (modified Rankin score 0-2),
- NIHSS score>5,
- Neuroimaging study including at least one non-contrast cranial CT scan within 60 minutes of arrival at the hospital center.
- SUBSTUDY 2. OPTIMIZATION OF CIRCUITS AND TRANSFER MODEL IN PATIENTS WITH STROKE IN THE EXTENDED WINDOW OF TREATMENT.
- Inclusion criteria: Selection of consecutive, prospective patients to be included in the CICAT registry between January 2023 and March 2024 with stroke meeting the following criteria:
- Age over 18 years,
- Suspicion of acute cerebral infarction,
- More than six hours of evolution or uncertain chronology of symptoms,
- absence of pre-stroke disability (modified Rankin score 0-2),
- NIHSS score greater than 5.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Stroke in the Extended Window: Optimization of the Radiological Selection and Transfer Model in Patients With a Stroke Presenting 6-24h After Symptoms Onset (VESTA Study)
We aim to optimize the radiological selection and the transfer model in patients with a 6-24h stroke for a fairer and broader access to a reperfusion treatment. The specific objectives are:
- To confirm that the selection of patients for reperfusion therapies in the late window is safe by applying the same clinical and imaging criteria recommended by clinical guidelines for the early window treatment selection.
- To evaluate the performance of non-contrast CT by applying immediate post-processing software for the selection of patients for reperfusion treatment in the late window.
- To analyze the prehospital and arrival variables at the primary stroke center to generate decision trees that optimize the transfer decision in patients with activation of the stroke code in >6h from the onset of symptoms.
Read more
METHODOLOGY: Study based on a mandatory, prospective, multicenter registry (CICAT registry) consisting of two phases
- retrospective analysis with a detailed evaluation of the images of the included patients and generation of "machine learning" models that accurately predict the probability of receiving reperfusion treatment in the late window.
- validation of the models in a prospective study. Clinical, radiological and transport variables will be studied.
Response variables: rate of patients receiving reperfusion treatment in the late window, functional prognosis at 90 days, hemorrhagic transformation, and mortality.
- Conditions
- Stroke, Ischemic
- Being tested
- Multiparametric imaging, Non contrast CT+CT angiography
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiparametric imagingDiagnostic test
MR perfusion or multiparametric CT including NCCT, CTA and CTP
Non contrast CT+CT angiographyDiagnostic test
NCCT+CTA
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients 6-24h receiving non-contrast CT + CTA | Stroke patients 6-24h undergoing non-contrast CT + CTA to decide stroke therapy Receives: Diagnostic Test: Non contrast CT+CT angiography | |
| Stroke patients 6-24h receiving multimodal imaging | Stroke patients 6-24h undergoing NCCT+CTA+CTP or MRI with DWI and PWI imaging to decide stroke therapy Receives: Diagnostic Test: Multiparametric imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRS at 90 days
Percentage of patients with functional independence, defined as mRS < or =2 on day 90 as assessed centrally by blinded evaluators of the Catalan Stroke Master Plan.
Measured: 90 days after stroke
Rate of patients treated with mechanical thrombectomy
Measured: less than 24 hours after the diagnostic test
Secondary outcomes (2)
Mortality at discharge and at day 90
Measured: 90 days after stroke
Symptomatic intracerebral hemorrhage, defined as PH2 or SAH on imaging test at 24-72 hours associated with a worsening in NIHSS ≥ 4 points
Measured: From 24 to 72 hours after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start14 Jan 2022
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute
- Responsible party
- Principal investigator, María Hernández Pérez, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299034
- Sponsor's protocol ID
- PI21/01548
- Acronym
- VESTA
- Status last verified
- Aug 2023
- First submitted
- 13 Jan 2022
- Last updated
- 22 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Valls-Carbo A, Millan M, Castano C, De La Ossa NP, Cardona P, Flores A, Biarnes C, Boix M, Urra X, Terceno M, Olive-Gadea M, Renom PC, Rodriguez-Campello A, Purroy FF, Yugueros B, Canovas D, Caamano IR, Beltran-Marmol B, Remollo S, De Dios M, Bashir S, Aja L, Gramegna LL, Pastrana M, Hernandez-Perez M. Simple against advanced imaging for the selection of stroke therapy in the extended window (VESTA study). Eur Stroke J. 2026 Jun 2;11(6):aakag068. doi: 10.1093/esj/aakag068.
PubMed 42308555
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Stroke in the Extended Window: Optimization of the Radiological Selection and Transfer Model in Patients With a Stroke Presenting 6-24h After Symptoms Onset (VESTA Study)
- ClinicalTrials.gov ID
- NCT05299034
- Acronym / sponsor ID
- VESTA / PI21/01548
- Conditions
- Stroke, Ischemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,173 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- Carlos III Health Institute
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We aim to optimize the radiological selection and the transfer model in patients with a 6-24h stroke for a fairer and broader access to a reperfusion treatment. The specific objectives are:
- To confirm that the selection of patients for reperfusion therapies in the late window is safe by applying the same clinical and imaging criteria recommended by clinical guidelines for the early window treatment selection.
- To evaluate the performance of non-contrast CT by applying immediate post-processing software for the selection of patients for reperfusion treatment in the late window.
- To analyze the prehospital and arrival variables at the primary stroke center to generate decision trees that optimize the transfer decision in patients with activation of the stroke code in >6h from the onset of symptoms.
METHODOLOGY: Study based on a mandatory, prospective, multicenter registry (CICAT registry) consisting of two phases
- retrospective analysis with a detailed evaluation of the images of the included patients and generation of "machine learning" models that accurately predict the probability of receiving reperfusion treatment in the late window.
- validation of the models in a prospective study. Clinical, radiological and transport variables will be studied.
Response variables: rate of patients receiving reperfusion treatment in the late window, functional prognosis at 90 days, hemorrhagic transformation, and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke patients 6-24h receiving non-contrast CT + CTA | – | Diagnostic Test: Non contrast CT+CT angiographyStroke patients 6-24h undergoing non-contrast CT + CTA to decide stroke therapy |
| Stroke patients 6-24h receiving multimodal imaging | – | Diagnostic Test: Multiparametric imagingStroke patients 6-24h undergoing NCCT+CTA+CTP or MRI with DWI and PWI imaging to decide stroke therapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with stroke suspiction in Catalonia included in the CICAT registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiparametric imagingMR perfusion or multiparametric CT including NCCT, CTA and CTP | Diagnostic test | Stroke patients 6-24h receiving multimodal imaging |
| Non contrast CT+CT angiographyNCCT+CTA | Diagnostic test | Stroke patients 6-24h receiving non-contrast CT + CTA |
Primary outcome
mRS at 90 days
Time frame: 90 days after stroke
Percentage of patients with functional independence, defined as mRS < or =2 on day 90 as assessed centrally by blinded evaluators of the Catalan Stroke Master Plan.
Rate of patients treated with mechanical thrombectomy
Time frame: less than 24 hours after the diagnostic test
2 secondary outcomes
Mortality at discharge and at day 90
Time frame: 90 days after stroke
Symptomatic intracerebral hemorrhage, defined as PH2 or SAH on imaging test at 24-72 hours associated with a worsening in NIHSS ≥ 4 points
Time frame: From 24 to 72 hours after stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Derived from this study: PubMed 42308555Valls-Carbo A, Millan M, Castano C, De La Ossa NP, Cardona P, Flores A, Biarnes C, Boix M, Urra X, Terceno M, Olive-Gadea M, Renom PC, Rodriguez-Campello A, Purroy FF, Yugueros B, Canovas D, Caamano IR, Beltran-Marmol B, Remollo S, De Dios M, Bashir S, Aja L, Gramegna LL, Pastrana M, Hernandez-Perez M. Simple against advanced imaging for the selection of stroke therapy in the extended window (VESTA study). Eur Stroke J. 2026 Jun 2;11(6):aakag068. doi: 10.1093/esj/aakag068.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic, run by Germans Trias i Pujol Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRS at 90 days (time frame: 90 days after stroke). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05299034, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.